Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography (HD-FFRct)

Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: ElucidVivo

Detailed Description

Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.

• Study Type: Observational
• Enrollment (Actual): 302

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects for which a CCTA had been taken within 60 days of invasive coronary angiography with FFR measurements.

Description

Inclusion Criteria:

• Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
• CCTA was no more than 60 days earlier (and not later)

Exclusion Criteria:

• Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
• Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low FFR; Invasive FFR value <= 0.8	Device: ElucidVivo; Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)
High FFR; Invasive FFR value > 0.8	Device: ElucidVivo; Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	the ability of a test to correctly identify patients with low FFR	1 day
Specificity	the ability of a test to correctly identify people without low FFR	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Error	Difference of noninvasive result - invasive result	1 day

Collaborators and Investigators

• Sponsor: Elucid Bioimaging Inc.
• Collaborators: Medical University of South Carolina; The Christ Hospital; Mie University; St. Francis Medical Center, New Jersey
• Investigators: Principal Investigator: Andrew J Buckler, Elucid Bioimaging Inc.

Publications and helpful links

General Publications

• Varga-Szemes A, Schoepf UJ, Maurovich-Horvat P, Wang R, Xu L, Dargis DM, Emrich T, Buckler AJ. Coronary plaque assessment of Vasodilative capacity by CT angiography effectively estimates fractional flow reserve. Int J Cardiol. 2021 May 15;331:307-315. doi: 10.1016/j.ijcard.2021.01.040. Epub 2021 Jan 30.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: HD-FFRct

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes